UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM

  • BHAGYASHRI S. SHINDE Department of Quality Assurance D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India
  • M. S. KALSHETTI Department of Quality Assurance D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India
  • ANJALI P. KOKANE Department of Quality Assurance D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India

Abstract

Objective: A new sensitive, economical, simple, rapid UV spectrophotometric method has been developed for the estimation of Saxagliptin in API and pharmaceutical formulation.


Methods: Calibration curve method was used for the estimation of Saxagliptin in API and pharmaceutical formulation.


Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ. Linearity was found in the range of 10-60µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. All the parameters were validated as per the ICH guidelines.


Conclusion: This method is suitable forused routine analysis of present Saxagliptin in API and Pharmaceutical dosage form.

Keywords: Saxagliptin, UV spectrophotometer, Method validation, Methanol

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SHINDE, B. S., M. S. KALSHETTI, and A. P. KOKANE. “UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM”. International Journal of Current Pharmaceutical Research, Vol. 12, no. 5, Sept. 2020, pp. 63-66, doi:10.22159/ijcpr.2020v12i5.39768.
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